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Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19

Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04912921
Enrollment
115
Registered
2021-06-03
Start date
2020-10-20
Completion date
2022-05-15
Last updated
2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, COVID19

Keywords

palmitoylethanolamide, curcumin

Brief summary

Two randomized controlled trials will be conducted to examine the effect of a food supplement on proinflammatory cytokines and biomarkers in an adult population recently diagnosed with COVID-19 who are asymptomatic or experiencing only mild symptoms. The supplement, palmitoylethanolamide (PEA), is marketed under the trademarked product with increased bioavailability and format versatility: Levagen+™ (Gencor Pacific Limited, Irvine, CA). The supplement curcumin is marketed under the trademarked product with increased bioavailability: HydroCurc (Gencor Pacific Limited, Irvine, CA)

Detailed description

Inflammation is at the core of many chronic conditions and exacerbates infectious conditions, and inflammatory responses appear to be key determinants of the severity of COVID-19 infection. Hence, controlling inflammation is considered a key strategy for slowing the progression of disease and tissue pathology. This research offers a natural, dietary approach to managing inflammation by reducing the mediators of inflammation. The beneficial effects of palmitoylethanolamide (PEA) and for curcumin for reducing inflammation is documented in the research literature. The proposed research will expand this literature in a novel manner. The investigators propose to demonstrate the efficacy of these dietary supplements in individuals from a campus population with robust immune protection - those who recently tested positive for COVID-19 but were asymptomatic or mildly symptomatic. Since a college population is under many stressors which raise inflammatory profiles during the academic year, and since a college population is exposed to infectious agents on campus, maintaining strong protective immune system following a COVID-19 infection is important.

Interventions

DIETARY_SUPPLEMENTpalmitoylethanolamide

4 tablets taken daily (2 in the am and 2 in the pm)

DIETARY_SUPPLEMENTPlacebo

4 tablets taken daily (2 in am and 2 in pm)

DIETARY_SUPPLEMENTCurcumin

500 mg HydroCurc® twice a day

DIETARY_SUPPLEMENTControl (microcrystalline cellulose)

2 tablets taken daily

Sponsors

Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Masking description

Palmitoylethanolamide and placebo tablets are identical in appearance and presented to participant in unlabeled opaque containers by investigators blinded to container content. Curcumin and control tablets are identical in appearance and presented to participant in unlabeled opaque containers by investigators blinded to container content

Intervention model description

double-blind, randomized, controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Male and females 18-65 years old * Generally healthy * Able to provide informed consent * Recent positive COVID-19 test (per RT-PCR Test)\*

Exclusion criteria

* Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, HIV, lung conditions or chronic asthma) * Serious mood disorders, neurological disorders such as MS, or cognitive damage * Active smokers and/or nicotine or drug abuse * Active, regular marijuana or other cannabinoid use, other street/recreational drug use * Chronic past and/or current alcohol use (\>14 alcoholic drinks week) * Allergic to any of the ingredients in active or placebo formula including peanuts, eggs or turmeric * Pregnant or lactating woman * People medically prescribed to take drugs that would affect the immune and/or the inflammatory response * People who have had treatment (last 5 years) for cancer, or chronic use of steroids * BMI \>40

Design outcomes

Primary

MeasureTime frameDescription
IL6 concentrationchange from baseline at day 28interleukin-6

Secondary

MeasureTime frameDescription
serum ferritin concentrationchange from baseline at day 28serum ferritin
serum ICAM concentrationchange from baseline at day 28Intercellular Adhesion Molecule 1
serum CRP concentrationchange from baseline at day 28C-reactive protein (high sensitivity)
serum white blood cell differentialchange from baseline at day 28white blood cell differential
serum p-selectin concentrationchange from baseline at day 28cell adhesion molecule
serum NFk-beta concentrationchange from baseline at day 28nuclear factor kappa-light-chain-enhancer of activated B cells

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026